This study would be a prospective cohort study, stratified by weight. Patients who are stable on nevirapine for at least 3 months prior to study entry, but no more than 1year will be recruited. For 1 week, subjects will take their morning dose of nevirapine in the clinic (and be observed taking it), and given their evening dose to take at home. Subjects will need to record the date and time they take their evening dose. At the end of the week, the subjects will be sequestered at the clinic for blood draws for a 12hr pharmacokinetic sampling. They will not be brought back in at 24hrs as they will need to be redosed after 12hrs. They will have Liver Function Tests (LFT's) and other labs drawn at study entry, and one month after the end of study. Pharmacokinetic levels will be analyzed using standard mathematical models, and Area Under the Curve (AUC), Maximum concentration (Cmax), and Minimum Concentration (Cmin) will be compared between groups.

Further study details as provided by Western University of Health Sciences:

Primary Outcome Measures:

Differences in AUC based on weight/BMI [ Time Frame: 12 hours ] [ Designated as safety issue: No ]

This study was a "snapshot" of the PK levels following ingestion, and then compared AUC to weight and BMI.

Biospecimen Retention: None Retained

Levels were drawn prior to dosing, and at the following time intervals: 0.5hr, 1hr, 1.5hr, 2hr, 4hr, 6hr, 8hr, 12hr. ~10cc of blood were drawn with each sample, centrifuged, and plasma separated into 2 cryovials. Samples were then frozen at -20oC. All samples (216) weresent to Consolidated Laboratory Services for level determination by appropriate means. All samples have now been destroyed.

In good health as judged by their primary care provider or a study provider within one month of the study date

Willing to abstain for 1 week prior to study date

No active opportunistic infections within one month prior to the study date

Willingness to sign informed consent

Exclusion criteria:

Active substance abuse

Poor self reported adherence to nevirapine therapy

Chronic liver disease or active hepatitis

Concurrent administration of medications with a known or suspected pharmacokinetic drug interaction with nevirapine (such as …)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335360